Verona Pharma Q3 2024 Earnings Call Transcript

Quartr
Provided by Quartr
November 4, 2024

There are 11 speakers on the call.

Operator

Good morning, everyone, and welcome to Verona Pharma's Third Quarter 2024 Financial Results and Operating Highlights Conference Call. At this time, all participants are in a listen only mode. Earlier this morning, Verona Pharma issued a press release announcing its financial results for the 3 months ended September 30, 2024. A copy can be found in the Investor Relations tab on the corporate website, www. Veronapharma.com.

Operator

Before we begin, I'd like to remind you that during today's call, statements about the company's future expectations, plans and prospects are forward looking statements. These forward looking statements are based on management's current expectations. Statements are neither promises nor guarantees and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward looking statements. Any such forward looking statements represent management's estimates as of the date of this conference call. While the company may elect to update such forward looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change.

Operator

As a reminder, this conference call is being recorded and will remain available for 90 days. I'd now like to turn the floor over to Doctor. David Zaccardelli, Chief Executive Officer. Sir, you may begin.

Speaker 1

Thank you, and welcome, everyone, to today's call. We are extremely pleased to be with you today to share our remarkable achievements in the Q3, highlighted by the launch of OTUVAIR. With me today are Mark Hahn, our Chief Financial Officer Doctor. Kathy Rickard, our Chief Medical Officer Chris Martin, our Chief Commercial Officer and Doctor. Tara Rowe, our Chief Development Officer.

Speaker 1

The Q3 was exceptional for Verona Pharma marked by the U. S. Launch of O2VARE for the maintenance treatment of COPD and continued progress on our clinical development programs. First, let's review the outstanding launch of O2VARE, which is grounded in its broad COPD indication and the compelling benefits O2vera provides to COPD patients. After just 7 weeks, net product sales were $5,600,000 for the Q3.

Speaker 1

We are excited as demand for OTUVERA continues to escalate with net sales for October exceeding the Q3. Now let's review some key launch metrics. Through the end of October, only 12 weeks after fully launching O2Vare, more than 5,000 O2Vare prescriptions have been filled with more than 2,200 unique HCPs prescribing O2Vare. Our launch efforts continue to focus on promoting O2VARE to the highest prescribing 14,500 HCPs. In 12 weeks, approximately 30% of our 2,500 Tier 1 HCPs have prescribed O2VARE.

Speaker 1

As a reminder, Tier 1 HCPs write on average 150 COPD maintenance treatment prescriptions per month. We also continue to see that once an HCP prescribes O2VARE, they increase their prescribing to more patients in their practice. We are impressed by the breadth and depth of prescribers and prescriptions this early in the launch. Importantly, HCPs are prescribing O2VARE across a broad range of COPD patients, including background single, dual and approximately 50% on triple therapy. This broad utilization across all patient types is consistent with our market research and continues to highlight the significant unmet need across the COPD patient population.

Speaker 1

Initial feedback from both patients and health care providers about the potential of O2Fare to deliver a meaningful impact against COPD regardless of disease severity and background therapy is extremely encouraging and is all supported by the early refill data. Our commercial activity to engage HCPs continue to increase month over month. Through the 1st 12 weeks of launch, we have reached more than 90% of our Tier 1 and Tier 2 HCPs through in person or digital promotion. Our speaker programs with HCPs continue to accelerate, and we expect to have approximately 120 programs completed by the end of 2024. We recently presented new analyses from the Phase 3 ENHANCE study evaluating OTUVAIR in COPD.

Speaker 1

Presentations at CHEST and ERS conferences highlighted subgroup and pooled efficacy and safety analyses from the ENHANCE trial, as well as the impact of O2VARE on COPD related healthcare resource utilization and the unmet need in COPD based on real world claims data. At CHEST, our team interacted with approximately 1500 HCPs at our medical and commercial booths for O2VARE, highlighting the high level of interest in O2VARE from HCPs. While it is still very early in the launch, we are extremely encouraged by the strong start to the U. S. Commercialization of OTUVAIR.

Speaker 1

OTUVAIR is the 1st inhaled COPD treatment to provide both bronchodilation and non steroidal anti inflammatory effects, and we are confident that it can be defined in the COPD treatment paradigm. We are also pleased to report the Centers For Medicare and Medicaid Services recently approved a permanent product specific J code for OTUVAIR, which will be effective in January 2025. Alongside our successful O2VARE launch, we initiated 2 new Phase 2 clinical programs during the Q3. In September, enrollment began in a Phase 2 dose ranging trial supporting a fixed dose combination formulation with ensifentrine and glycopyrrolate, ALAMA, for the maintenance treatment of COPD delivered via a standard jet nebulizer. The dose ranging trial is a randomized double blind placebo controlled 1 week crossover trial to assess lung function, safety and the pharmacokinetic profile of glycopyrrolate delivered via nebulizer in approximately 40 subjects with COPD.

Speaker 1

Following identification of an appropriate glycopyrrolate dose range, a Phase 2 trial assessing the fixed dose combination of ensifentrine and glycopyrrolate will be conducted. Also in September, enrollment began in the Phase II trial to assess nebulized ensifentrine in patients with non cystic fibrosis bronchiectasis. The randomized double blind placebo controlled parallel group trial will enroll 180 subjects with a recent history of pulmonary exacerbations. The trial will assess the effect of ensifentrine 3 milligram twice daily on the rate and risk of pulmonary exacerbations, symptoms and quality of life. To ensure robust powering, the trial is event driven with all subjects treated for at least 24 weeks and until the required number of exacerbation events are observed.

Speaker 1

Finally, turning to our global strategy. Nuance Pharma, our development partner for ensifentrine in Greater China, announced it has completed enrollment in its pivotal Phase 3 clinical trial evaluating ensifentrine for the maintenance treatment of COPD in China. Nuance Pharma expects to provide results from the pivotal Phase 3 clinical trial in 2025, and we look forward to providing an update next year. I will now turn the call over to Mark to review our financial results for the Q3.

Speaker 2

Good morning. The Q3 was an exciting one for Verona as we recorded our first sales of Eutuber. For the partial quarter starting in August and ending on September 30, 2024, we recorded O2VARE net product sales of $5,600,000 As expected, our specialty pharmacy partners are holding inventory at their contracted level of 2 to 3 weeks. Cost of goods sold related to O2Vare was $500,000 for the quarter ended September 30, 2024, which consisted of supply chain, post approval production cost of inventory sold and royalties payable to Ligand. Recall that O2VARE was approved in June 2024 and prior to receiving FDA approval, costs associated with the manufacture of O2VARE were expensed as R and D expense.

Speaker 2

Research and development costs were $10,600,000 for the quarter ended September 30, 2024 compared to $3,000,000 reported for the Q3 of 2023. The increase was primarily due to a $7,800,000 increase in clinical trial costs as we initiated 2 Phase II trials over the course of the quarter. Selling, general and administrative expenses were $35,200,000 for the quarter ended September 30, 2024 compared to $13,400,000 reported for the same period in 2023. The increase was driven primarily by a $9,700,000 increase in people related costs and $2,800,000 in share based compensation, primarily related to our field sales team. In addition, marketing and other commercial related activities, including travel increased by $7,500,000 and professional and consulting fees, information technology costs and other related support costs increased by $1,600,000 as we continue to build out our organization.

Speaker 2

For the quarter ended September 30, 2024, net loss after tax was $43,000,000 compared to a net loss after tax of $14,700,000 for the same period in 2023. This represents a loss of $0.07 per ordinary share or $0.53 per ADS for the quarter compared to a loss of $0.02 per ordinary share or $0.18 per ADS for the Q3 of 2023. Finally, our balance sheet remains strong with $336,000,000 in cash and equivalents as of September 30, 2024. With the cash currently on hand and potential future access to the remaining $425,000,000 under the Oaktree facilities, we expect to have sufficient runway through at least the end of 2026 as we continue the commercial ramp of O2 Bear in the U. S.

Speaker 2

And execute on our 2 ongoing Phase 2 clinical trial programs. I'll now turn the call back over to the operator for the Q and A.

Operator

Ladies and gentlemen, at this time, we'll begin that question and answer session. And our first question today comes from Andrew Tsai from Jefferies. Please go ahead with your question.

Speaker 3

Hey, good morning. Thanks for taking my questions and congrats on the strong launch and the strong execution. First question is, your the data point around October net sales exceeding Q3. So does that mean we're run rating at least 17,000,000 dollars for Q4 without considering any type of growth in November December? Or should we start to think about some new variables that could come into play like holiday period or patients starting to drop out?

Speaker 3

Or do you think the sheer volume of patient adds can offset any type of headwinds like these discontinuations? Thanks.

Speaker 4

Good morning, Andrew. Thanks for the question. Yes, so clearly, we're not providing any guidance for Q4. I think your math stands as it is. At this time, we don't see any reason or rationale for any slowdown in the number of patients and the interest and the acceleration that we've seen in October.

Speaker 4

And so we'll of course closely monitor it and continue our efforts as we have in the past several weeks. So we look forward to continued acceleration of use of O2 there. Clearly, there's been a lot of interest as has already been demonstrated, a lot of need as we've talked about in the past for an additional novel mechanism like O2VARE and COPD. And we continue to get incredible feedback from physicians and patients for that matter, really looking forward to utilizing Eutuver in their treatment paradigm. So we're very excited about what has occurred in this very early part of the launch over the initial 12 weeks and we expect that to continue.

Speaker 3

Very good to hear. And then just as a follow-up, 5,000 prescriptions filled through October, by chance are you willing to disclose how many unique patients you have as of October? And any other metrics you're planning to provide in the next earnings call?

Speaker 4

Yes. No, thanks. I think the best way to characterize it at this point is it's very fluid as you can imagine that patient adds are increasing week over week. Of the over 5,000, of course, the majority of those are vast majority of those are unique patients. Refills have started as they should, although very early on in that process, as some of the first patients are starting to be refilled, from earlier in the launch.

Speaker 4

So I think it's best to characterize it as accelerating at this time. There's a substantial number of patients that have been referred in over the past couple of weeks as we expect. Those are continued to be processed and we expect the patient has to continue to grow.

Speaker 3

Great. Congrats again.

Speaker 5

Thanks, Andrew.

Operator

And our next question comes from Yasmeen Rahimi from Piper Sandler. Please go ahead with your question.

Speaker 6

Yes. Good morning, team and congrats on a great quarter. I want to stick with the theme of Andrew's question. I guess it seems like things are progressing really well. But can we talk about past December into 2025?

Speaker 6

Like should we be expecting that in the beginning of the year before JPMorgan you could come out and provide some consensus or some guidance in terms of what revenue expectations are? I think it seems like you've had a great quarter, but there's just a lot of room trying to figure out how the next 5 quarters are going to go. So is there an opportunity to kind of help us understand like beyond Q4 what things are going to look like in 1Q2, Q3Q? That's question 1. Question 2 is do you have any insight on who are what are the type of patients that are being prescribed Odovera.

Speaker 6

We recently did a KOL call and shockingly found out that the doctor was noting that majority of his patients are on patients who failed triple therapy. So even if you don't have quantitative numbers, what are you hearing from the doctors in terms of how they're using Odevair? And then the third question is like, where do you want to be in terms of physician outreach in the next by year end, by mid next year? Sorry for the sort of 3 part long questions. And I'll jump back in the queue.

Speaker 4

Great. Good morning, guys. Thanks for those questions. I'll sort of not take them in any particular order. But I first would characterize it as I mentioned during the call, the O2VARE is being prescribed broadly across all patient segments, including patients on background single, dual and triple therapy, as we expected.

Speaker 4

With regard to triple therapy, nearly 50% of the prescriptions are on pace for patients that are on triple therapy. So I think we're very encouraged by the breadth of prescribing across all patient types. And as we expected from our market research, that there was keen interest in using OTUVAIR in patients who were on triple therapy and still needing improvement. We knew that was a large unmet medical need and that's how physicians are also utilizing it as well as another patient types earlier on in the treatment paradigm. With regard to forecasting, I think it's a little premature at the moment to review it.

Speaker 4

I think we'll need to assess the continued launch dynamics through the Q4, which we will. I think you've seen historically, we are very transparent and we'll provide you the guidance the best we can, while not getting ahead of ourselves and making sure that we characterize it properly. But we're very encouraged, very excited. And as you can see, there's great interest in utilizing O2VARE. And so we expect 2025 to be an enormous year of growth and utilization of O2VARE in the treatment of CRPD.

Speaker 4

And we'll look to characterize that. I guess I'll turn it over to Chris on maybe where we'd want to be in outreach over the coming quarters.

Speaker 5

Hello, Yaz. Thank you for the question. I think when we think about physician outreach, we continue to focus on our Tier 1 and Tier 2 physicians. Those, as Dave mentioned on the call, are 14,500 doctors give or take. And on average, the Tier 1 is right about 150 prescriptions and the Tier 2 is around 50.

Speaker 5

We want to continue to reach them and increase our frequency against these customers as we move into Q4 and into Q1. One of the things that we've seen early in launch is as increase the interactions we have with these physicians, their ability and willingness to adopt O2 there accelerates. And we believe that's an important aspect as we move into Q4 and Q1 and into 2025 is to continue to reach as many as we can, but also increase our frequency and the times that we call on them, not only with reps, but interacting with them through digital non personal channels as well. We see this provides direct benefit to their increasing in their overall prescribing.

Speaker 6

Thank you. I'll jump back in the queue.

Operator

Our next question comes from Ram Selvaraju from H. C. Wainwright. Please go ahead with your question.

Speaker 7

Thanks so much for taking my questions and congrats on all the progress. Really very impressive commercial metrics here. Firstly, I wanted to ask if you could comment on any emerging prescriber trends, particularly with respect to preferences in combination regimens that prescribers are expressing they have a predilection for with respect to ensifentrine? Are there specific existing modalities that they are preferring to pair ensifentrine with? Or are you really just seeing sort of no preference and the drug effectively being very broadly deployed without any underlying emergent trends at this point?

Speaker 4

Yes. Hi. Good morning, Ram. Thanks for the question. Yes, I would say it's really the latter.

Speaker 4

I think that what we're seeing is a prescribing across the spectrum of patients. As I mentioned, patients on single, dual and triple therapy with no particular stated interest in certain combinations or certain drugs or certain LAMAs or LABA, but rather the classes as they're generally utilized interchangeably in practices. As I mentioned, there is a great interest of course using it on top of triple therapy as nearly 50% of the patients are on triple therapy currently. And we expected that, again, feedback from physicians is very positive. And they're seeing, again, responses as they'd expect to in patients being treated early on in the launch.

Speaker 4

So again, very, very excited and really shows how much O2 there and a novel mechanism was needed in the treatment of COPD and we're seeing it utilized again across the spectrum of patients. And again, currently a preference on top of triple only because that was of course the highest unmet medical need as those patients really have nowhere else to go in treatment and if they remain symptomatic on triple, O2 vera is definitely being preferred.

Speaker 7

Great. Thanks. And then with respect to the clinical indications that you are now starting to pursue proof of concept clinical evidence for, in particular bronchiectasis, can you talk a little bit about how the commercial experience with OTUVAIR, increasing awareness of OTUVAIR among prescribers is likely to frame these additional opportunities and how you go about pursuing them. Have those prescribers who've effectively acquainted themselves with the product since it's been launched expressed an interest in the progress of those additional indications as the drug continues to move forward on fronts beyond COPD?

Speaker 4

Yes. No, thanks for the question, Ram. I think that our interest in using ensifentrine in non CF bronchiectasis came from a number of avenues, one of them being an incredibly strong interest from KOLs, physicians that as we consulted with them, it made great sense to them that ensifentrine pharmacology as a PD3, PD4 inhibitor as a bronchodilator and a non steroidal anti inflammatory could have great promise in bronchiectasis. And so clearly there's interest broadly from physicians in it. With that said, of course, we're very focused on O2VARE and COPD, specifically on the commercial front.

Speaker 4

We will continue to progress ensifentrine in research and in clinical development for non CF bronchiectasis as we are now progressing with our Phase 2 study. I think we will all see how that looks in the future as that study ultimately because exacerbation is an endpoint and it's at least a 24 week trial, you're talking about data probably well into 2026 at the moment, but let's get the trial enrolled and see where we're at.

Speaker 7

Great. And then lastly, this is just an accounting question. You mentioned earlier that certain expenses associated with manufacturing product prior to launch have now been shifted into the SG and A line or away from the R and D line as it were. So I was just wondering if you could give us a general maybe qualitative breakdown of which expenses going forward are likely to be segregated into the R and D line versus the SG and A line? For example, the speaker programs, how are you accounting for those?

Speaker 7

Are there any expenses, in other words, that are associated with effectively commercial activities that you are going to continue to book in the R and D line item? Thanks.

Speaker 2

Yes. Ram, this is Maher. Thanks for the question. The numbers that I was referring to were specifically related to inventory production costs. And so before approval, those were expensed as R and D.

Speaker 2

And you can imagine since it's a blow filled sealed product that the finished goods were produced after approval, so therefore put into inventory. But the API was produced before approval and that would have been expenses R and D expense. All the commercial costs, speaker programs, travel, etcetera, marketing programs, all get expensed in the period in which they're incurred as part of SG and A expense.

Speaker 7

Great. Thank you very much. Congrats once again.

Speaker 4

Thanks, Ram.

Operator

And our next question comes from Tom Shrader from BTIG. Please go ahead with your question.

Speaker 8

Thank you and congratulations. Just looking at the physician number and the prescription number, it seems like you have a lot of people writing 1 or 2 prescriptions to try the drug. Do you know what they're looking for to get more excited? And I guess the flip side is, I assume you have some power users. What do they tell you to refine your marketing pitch as to why they're already committed?

Speaker 8

So thanks.

Speaker 4

Yes, Tom. Let me just make a few comments and I'll turn it over to Chris for more detail. I think it's yes, of course, there are physicians who prescribe it 1 or 2 patients and want to see how it works in their hands and in their patients. Clearly, that's a typical behavior that can be expected and that goes on. As you mentioned, there are also physicians which are, let's just say, heavy adopters and are prescribing it quite a bit within their practice as they've seen responses in patients and as they've had really a need in order to use O2VARE in their practice.

Speaker 4

So we're seeing the spectrum of that. I think it's also also challenging to look at prescriber numbers and patient prescriptions and all of that because it's very fluid as I referred to in that. Just in the past couple of weeks, there are substantial numbers being written that are currently in process on the process on the payer side as well as being adjudicated and make sure that they're going to be filled and going through that process. So any numbers are out of date literally by the end of the day. And so we're trying to characterize for you and being very transparent about where we stand at the moment.

Speaker 4

But your characterization is also correct in how physicians look at it in their practice. And maybe, Chris, you can comment on it.

Speaker 5

Yes, Tom. As far as when we look at the breadth and depth of these prescribers, one of the things that's been very encouraging to us and very exciting to us is the fact that what we see is, like you discussed, there's many physicians that start writing off 1 or 2, but we also see over the course of the launch in these early stages that once they write 1 or 2, they're exposed to the patient feedback, they continue to accelerate their usage. I think that's something Dave mentioned in his opening comments. What we see is it's a combination of patient experience and also increased frequency and interactions with our field sales personnel. We have to keep in mind that these doctors have been doing the same thing for 10 to 15 years and O2VARE as a novel mechanism and as an add on across all the spectrum of COPD patients that remain symptomatic in their practice is something that we have to continue to talk to them about.

Speaker 5

And they are extremely excited about what O2VARE can provide and then ultimately what O2VARE can do to help their patients. So I think what we see early on is very, very encouraging from adoption and then moving from 1 to 2 to what we would call believers and a doctor who is much more entrenched in using O2VARE.

Speaker 8

I'd like to ask a quick follow-up on your infrastructure. How often are you giving patients drug for a month and what is your conversion rate looks like? How does all that stuff you set up seem to be operating?

Speaker 5

Yes. Good question, Tom. We're very pleased with how our infrastructure has been set up. I think one of the things that we talked about very early on was our data infrastructure and the infrastructure to understand where these patients are and that has worked extremely well so that we're able to understand and kind of work to make sure that patient gets access to the drug. What I will say today is that of those 5,000 dispense scripts, the majority, a significant majority of those are paid TRxs.

Speaker 5

We're seeing very positive trends within the payer side. We talked about Medicare Part B and medical benefits and all those assumptions that we had earlier on are playing out to be very consistent and true to what we thought going into launch. So that makes us very encouraged about the systems and the process that we put in place.

Speaker 8

Great. Thanks and congrats again.

Speaker 4

Thanks, Sam.

Operator

Our next question comes from Edward Thomason from VLK. Please go ahead with your question.

Speaker 9

Good afternoon. Good morning. Thank you for taking my question and good to see the prints today. Well done. Just a question please on the ramp up again.

Speaker 9

You mentioned this specifically to Mark about inventory build. Can you just go talk through the dynamics there so we can better understand how that is playing out? And then roughly if you can split it out, how much of a percentage of that of the initial sales we saw in Q3 is actually in market sales versus inventory build?

Speaker 2

Thanks, Edward. I'm not sure I quite understood the second part of that question. Can you repeat that part?

Speaker 9

I just asked whether you can disclose how much of the sales that was reported in Q3 relates to inventory build versus actual in market sales.

Speaker 2

Okay. In the inventory build in the channel. Sure. So we haven't disclosed the number, but you can imagine that in a period of rising sales, they're building their inventory and holding about 2 to 3 weeks depending on the different specialty pharmacy partner. It could be anywhere in that range.

Speaker 2

Nobody more than 3 weeks on hand. And so you can imagine that we've been on the market for 8 weeks at the end of September. So probably about a quarter or so of the inventory of the sales would be in inventory at that time.

Speaker 9

Okay. That's good to know. And then a separate question actually relates to the IP. I noticed a slight change where you've now talked about a couple of additional patents pending, notably one that's on COPD exacerbations. Can you just talk through how important that patent might be to commercial prospects?

Speaker 9

And does that patent relate just to ensifentrine or specifically the use of PD3, PD4s against COPD exacerbations?

Speaker 4

Yes. So let me talk broadly of course, all our IP is I think very important as when you look at it holistically. We did file a number of patents as you're referring to. The effect on exacerbations is one of them after the ENHANCE results. Those are in process.

Speaker 4

We expect a number of them to be listed in the orange book over the coming year to year and a half as they continue to be prosecuted. All of those would are important again in the totality of them as they should be in protecting our intellectual property. So I think we were specific, of course, it's related to O2 there. And we'll see at the end of the day how the claims are agreed and constructed. But all our patents are important.

Speaker 4

Of course, it's grounded in our polymorph patent and our formulation patent and the additional patents related to the effect of O2 there are also critically important.

Speaker 9

Okay. And one last question, if I may. Just can you confirm how many patients from the ENHANZE clinical program have been converted into commercial prescriptions? And has there been demand amongst existing user base for OtaVARE?

Speaker 4

Yes. So we when we ended the enhanced clinical trials, patients were discontinued at the end of the trial. We did not have any long term follow-up studies ongoing. So as you know that time gap was substantial between the write up of the NDA plus the year of review at the FDA. So we wouldn't know which patients that were in the trial may have come back and be on commercial O2 there.

Speaker 9

Okay. Thanks very much for taking my questions.

Speaker 1

Thanks very much.

Operator

Our next question comes from Joon Lee from Truist. Please go ahead with your question. Hey, congrats on the strong quarter and thanks for taking our questions. Can you talk about reimbursement rate across government and commercial channels and the rate of prescription abandonment due to co pay or any reason? And then congrats on getting the permanent J code.

Operator

Is there any COPD treatment guideline or algorithm that is currently in the works that could be introduced soon given the newly approved agents in COPD? Thank you.

Speaker 4

So maybe I'll have Fritz just sort of comment on our general payer dynamics.

Speaker 5

Yes. So June, when we think about reimbursement right now, the majority, I'd say 80 plus percent like we thought are going through a medical benefit, either through Medicare traditional Medicare Part B or Medicare Advantage. And like we assumed at launch, these processes do not require prior significant hurdles for these patients to get. We're seeing movement within that medical benefit channel very, very, very well. What's also encouraging for us is across What's also encouraging for us is across the pharmacy benefit side, which is commercial or Medicaid, we see patients having access to O2VARE as well.

Speaker 5

It does require a prior auth within that process. Each plan is a little bit independent, but we're able to work through that with our SP partners in that process to get patients access to OTUVAIR. The other thing that we think is very encouraging is and again, like what we talked about early on in launch during the setup was of the patients that have been dispensed scripts about, let's just say, well over 80% of them have a copay of less than $10 So they have access to O2 Air and they have access to very low out of pocket cost as well. And I think this bodes very well for the brand long term as we think about how the launch accelerates. As far as your second question, which was regarding upcoming guidelines or conferences, we do know that the gold guidelines have a meeting in November, in a couple of days.

Speaker 5

At that guideline meeting, we believe that O2VARE has an opportunity to be placed in there. As we've talked about in the past, there is a dyspnea pathway and an exacerbation pathway within the guidelines. And O2VARE's unique novel mechanism of action with bronchodilation, non steroidal anti inflammatory allows the consensus guideline committee to be able to put OTUVAIR in a variety of different spots there. Again, we think this is only an upside for OTUVAIR. When we talk to physicians today, the big thing that we hear from our reps and the feedback back from HCPs is that we have patients that have persistent symptoms regardless of what therapy they are on, single, dual or triple background therapy.

Speaker 5

These persistently symptomatic patients need add on therapy and Eutuber can be a very good choice for all these patients to provide additional bronchodilation and potential non steroidal anti inflammatory effects as well.

Operator

Great. Well, if I could add one more. Chris, you mentioned previously that 50% of the use is as an add on to triple therapy, which is really interesting. Has that shifted at all in the 1st few months of launch?

Speaker 5

No, June. It's still very early to kind of say if there's been any shift. I think the thing that's very encouraging for us is we have add on use on top of triple, but what you also see is about 50% of these other patients aren't on triple. So remember our market research early on said that O2VIR could be used alone or as an add on across all lines of therapy. And in these first through October, we're seeing that.

Speaker 5

While we're seeing about 50% of patients on triple, we're also seeing patients on a single bronchodilator. We're seeing patients on LABA ICS being added O2 there. And that is all consistent with what we said in our early market research. And when I think about the health of a launch and the health of what does the ongoing 2025 look like, being able to say that some of that real work that we did early about unmet need and patient utilization, we're seeing that play out in these first few months of launch and that gives us a lot of encouragement for Q4 2025.

Operator

Really encouraging. Well, thank you so much. Thanks, Jim. Our next question comes from Bhavan Rishaiyappan from Roth Capital Partners. Please go ahead with your question.

Speaker 10

Good morning, Tim. Can you hear me?

Speaker 4

Yes, of course. Good morning.

Speaker 10

All right. Good morning. Thanks so much for taking our questions and congrats on the progress. So we have 2. Firstly, there's been some developments in the COPD landscape, most notably the recent approval of Dupixent.

Speaker 10

So we are wondering, do you expect potential headwinds from DUP as you think about penetrating the subsection of the COPD market comprising patients who are on triple therapy? And is there a motivation for prescribers to prioritize ensifentrine over DUPE excluding the cost benefits offered by ensifentrine?

Speaker 4

Yes. Good morning. Thanks for the question. I think again, it's good for patients with COPD to have choices. It was good to see the approval of Dupixent for the treatment of COPD.

Speaker 4

I think it highlights the need that exists for additional treatments. With that said, as you well know, Dupixent addresses a relatively narrow patient population or narrow part of the market. Those patients who are on triple therapy, have a history of exacerbations, have an elevated eosinophil count. And, by Sanofi, Regeneron's own estimation, it's in the U. S.

Speaker 4

About 300,000 patients. So relatively modest number considering there are about 8,500,000 patients who are on maintenance treatment. Because of the large patient population and unmet medical need across the board, we don't see it impacting the commercialization of O2VIR at all. And if anything, again, brings a spotlight on to the need for treatments in helping patients who are currently symptomatic and needing additional therapy. And even with that said, there is no specific rationale that we know of why O2VARE could not be used with Dupixent and if the physician felt that that was the right combination for that patient as well.

Speaker 4

Completely different pharmacology mechanism of action, of course, addressing inflammation from multiple modes could be beneficial. And of course, O2VAR's bronchodilation and impact on improving lung function acutely and helping with dyspnea on a day in and day out basis is key to what seems to as well, which some of the other types of approaches don't have that acute bronchodilation. So again, I think it's very good across the board and doesn't change our view because again of the large patient population and unmet need.

Speaker 10

Yes. Thanks for the clarity, David. And then maybe a second one and also the final one. So you mentioned about 2 Phase 2 clinical programs. I was looking at the clinical trials website this morning and this website also included a trial actually, you're currently recruiting for.

Speaker 10

It's the Phase 2 study to study the effect of ensifentrine on sputum markers of inflammation in COPD patients. So I understand the mechanistic implications of the study, essentially you wanted to see or know if ensifentrine interferes with AC PGP and PGP pathway. So that aside, but I'm curious how you plan to integrate the study outcomes into your clinical and commercial strategy? Is this specifically to collect more data potentially focusing on exacerbation and then maybe develop an add on clinical program or this could potentially trickle down to your cystic fibrosis program in some other way? How are you thinking about it?

Speaker 10

Thank you.

Speaker 4

Yes. I mean, I'll make a couple of comments and Tara, you can comment as well on the study itself. But I think again, this study is relatively small, but very mechanistic in nature, looking at the effects on sputum, markers in sputum and continuing to understand the deeper pharmacology of ensifentrine and specifically its PD3, PD4 inhibition. And I think as we see the outcome of this study, we will then look at that carefully and then utilize that data in the best way we can to help moving forward, whether in COPD or in other indications. And so with that, I don't know if Tara, you want to add anything else to that question?

Speaker 6

Yes. I think it's an 8 week crossover trial, looking at inflammation through the AC PGP pathway and also looking at inflammatory cell migration into the lung. So as Dave mentioned, as Dave mentioned, we do expect that to be helpful to better characterize the pharmacology events of centering in patients with COPD. Of course, we have already conducted a sputum study and healthy volunteers challenged with LPS and saw a nice effect across neutrophils, macrophages, eosinophils and lymphocytes. And so we do expect to see similar data in COPD patients, particularly given the strong and good observation results from the ENHANCE program.

Speaker 10

All right. Thanks so much for taking my questions.

Speaker 5

Thanks.

Operator

And ladies and gentlemen, at this time, we'll be ending today's question and answer session. I'd like to turn the floor back over to Doctor. Zaccardelli for any closing comments.

Speaker 4

Great. Thank you everyone for joining us on today's call and for your questions. In addition, I want to thank our shareholders for their support and especially the dedicated and talented team at Verona Pharma for their work and commitment. We are extremely excited about the launch of O2VARE and the advancement of our 2 Phase 2 trials as well. And we look forward to updating you on future calls and look forward to seeing you at conferences as well.

Speaker 4

Thanks very much and have a great day.

Operator

Ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We do thank you for joining. You may now disconnect your

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Earnings Conference Call
Verona Pharma Q3 2024
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